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Register of Telaprevir and Boceprevir in Routine Clinical Practice

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ClinicalTrials.gov Identifier: NCT02004379
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : July 15, 2015
Sponsor:
Information provided by (Responsible Party):
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud ( Fundación Pública Andaluza Progreso y Salud )

Brief Summary:
Know through routine clinical practice the effectiveness and safety of current treatment of hepatitis C virus, genotype 1, for patients who have never been treated and for patients who have been previously treated

Condition or disease
Hepatitis C

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1553 participants
Observational Model: Cohort
Target Follow-Up Duration: 12 Months
Study Start Date : November 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Group/Cohort
Patients with hepatitis C, genotype 1
Patients with hepatitis C, genotype 1, treated with telaprevir or boceprevir



Primary Outcome Measures :
  1. Effectiveness of current treatment of hepatitis C virus, genotype 1, for patients who have never been treated and for patients who have been previously treated [ Time Frame: 12 months ]
    Know through routine clinical practice the percentage of patients who have negative VHC-ARN

  2. Safety of current treatment of hepatitis C virus, genotype 1, for patients who have never been treated and for patients who have been previously treated [ Time Frame: 12 months ]
    Number and frequencies of serious adverse event (SAE) during the treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic hepatitis C, genotype 1, who are elegible to be treated with telaprevir or boceprevir
Criteria

Inclusion Criteria:

  • Patients infected by hepatitis C virus, genotype 1
  • Indication of treatment with telaprevir or boceprevir in F3 and F4 fibrosis

Exclusion Criteria:

  • Being taking part in other
  • Inability to follow a monitoring
  • Contra-indications on triple therapy
  • Coinfected with HIV and HBV (hepatitis B virus)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004379


Locations
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Spain
Hospital Universitario Doctor Negrín
Las Palmas de Gran Canaria, Gran Canaria, Spain
Hospital Comarcal Santa Ana
Motril, Granada, Spain
Hospital Universitario de Santiago de Compostela
Santiago de Compostela, La Coruña, Spain
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain
Hospital Son Espases
Palma de Mallorca, Mallorca, Spain
Hospital General Universitario Rafael Méndez
Lorca, Murcia, Spain
Agencia Sanitaria Costa del Sol
Marbella, Málaga, Spain
Hospital Universitario Nuestra Señora de la Candelaria
Santa Cruz de Tenerife, Tenerife, Spain
Hospital de Poniente
Almería, Spain
Hospital Torrecárdenas
Almería, Spain
Hospital Infanta Cristina
Badajoz, Spain
Hospital Universitario de Cruces
Bilbao, Spain
Hospital General de Ciudad Real
Ciudad Real, Spain
Hospital San Pedro de Alcántara
Cáceres, Spain
Hospital Puerta del Mar
Cádiz, Spain
Hospital Reina Sofía
Córdoba, Spain
Hospital Universitario de San Cecilio
Granada, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain
Hospital de Guadalajara
Guadalajara, Spain
Hospital Juan Ramón Jiménez
Huelva, Spain
Hospital San Jorge
Huesca, Spain
Complejo Hospitalario de Jaén
Jaén, Spain
Hospital Universitario A Coruña
La Coruña, Spain
Hospital de León
León, Spain
Hospital Ramón y Cajal
Madrid, Spain
Hospital Universitario de La Princesa
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Morales Meseguer
Murcia, Spain
Hospital Reina Sofía
Murcia, Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, Spain
Hospital Universitario Carlos Haya
Málaga, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
Hospital Universitario de Donostia
San Sebastián, Spain
Hospital Universitario de Valme
Sevilla, Spain
Hospital Universitario Virgen de la Macarena
Sevilla, Spain
Hospital Unviersitario Virgen del Rocío
Sevilla, Spain
Complejo Hospitalario de Toledo
Toledo, Spain
Hospital Arnau de Vilanova
Valencia, Spain
Hospital Clínico de Valencia
Valencia, Spain
Hospital General de Valencia
Valencia, Spain
Hospital la Fe
Valencia, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Spain
Hospital Universitario Río Hortega
Valladolid, Spain
Hospital de Zamora
Zamora, Spain
Hospital Clínico Universitario de Zaragoza
Zaragoza, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain
Sponsors and Collaborators
Fundación Pública Andaluza Progreso y Salud
Investigators
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Principal Investigator: Javier Salmerón Escobar Hospital Universitario de San Cecilio

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT02004379     History of Changes
Other Study ID Numbers: FPS-TEL-2013-01
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: July 15, 2015
Last Verified: July 2015
Keywords provided by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud ( Fundación Pública Andaluza Progreso y Salud ):
HCV
Hepatitis C
telaprevir
boceprevir
clinical practice
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections